Personal sound amplification products, also known as PSAPs or hearables, are consumer electronic devices that can help improve people's hearing. A wide variety of PSAPs are available, and have traditionally been sold online and in retail stores. The Food and Drug Administration (FDA) divides hearing aids and PSAPs into two distinct categories: Hearing aids are durable medical equipment intended to compensate for impaired hearing, whereas PSAPs are wearable electronic amplification devices marketed to consumers with normal hearing to amplify environmental sounds during recreational activities.1 Because these devices are available over the counter, audiologists do not need to be involved in an individual's decision to use a PSAP. These devices have become a source of disruption in the field of audiology, generating concern among some hearing care professionals that PSAPs and other over-the-counter (OTC) devices may make audiologists and their services irrelevant.
In 2019, the audiology department at Massachusetts Eye and Ear (Mass. Eye and Ear) in Boston began a project to determine how audiologists could evaluate these devices, dispense them to patients, and incorporate them into their clinical practice. The goal of this project was to start offering a wider variety of device options and expand access to improved hearing, in hopes of better serving patients who were not interested in or were not candidates for traditional hearing aids or those who were looking for a device intended for occasional use. By conducting electroacoustic analysis, changing the way clinicians approached a hearing aid selection, and using outcome measures, audiology practices can begin recommending, selling, and supporting PSAPs to improve access to hearing health care for patients with and without hearing loss.2
SELECTING AND EVALUATING DEVICES
Several types of patients may benefit from PSAPs. Patients who are not ready for amplification for either audiologic, financial, or personal reasons may find this option more realistic for their needs. Patients who report difficulty in a few specific environments may also benefit from these devices; most audiologists have encountered this type of patient, who reports that he or she can hear very well most of the time “except…” PSAPs may serve as a stepping stone for patients who could benefit from traditional amplification but are not yet ready for full-time device use. While device manufacturers can only market to individuals with normal hearing, many of these devices have the amplification required to benefit patients with up to a moderate degree of hearing loss.
With this population in mind, clinicians must decide which devices they want to recommend and sell. For those who are unfamiliar with PSAPs, it may feel daunting to sort through the hundreds of devices (which range in quality) to find a few high-quality devices to evaluate. Research on the internet, conference exhibit halls, and word of mouth may help make this process easier. After choosing a group of devices, clinicians can contact each device manufacturer to obtain a demo device for evaluation. They may purchase the PSAP and evaluate the device within the manufacturer's specified trial period. If the device lives up to a clinic's expectations, it can be kept as a demo for patients. If not, it can be returned for credit.
Each device should be evaluated for its electroacoustic capabilities, as well as its features for the audiologist and the end user. In our project at Mass. Eye and Ear, we determined these factors to evaluate: maximum output, distortion, and programmability (for the audiologist and the patient). We were mindful of choosing devices that were user-friendly, cost-effective, and gave the user some control over gain and frequency adjustments. We also wanted to have at least one option that did not require the user to have a smartphone to use the device.
The maximum output and distortion across a range of frequencies were recorded with a verified test box and compared across devices. We also wanted to determine how well these devices could be programmed to a patient's hearing loss. Each device we evaluated was programmed to three unique configurations of hearing loss using real ear measures in an attempt to meet NAL-NL2 targets for speech presented at 65 dB HL (Fig. 1). Standardized audiograms3 representing a mild, sloping, and flat moderate hearing loss were chosen, since we found that individuals with this type of hearing loss are the most common group looking to improve communication but not necessarily motivated to pursue traditional amplification.
This process revealed that not all PSAPs were user-friendly or easy to set up for testing. We found that several promising devices did not have sufficient output, had too much distortion, or offered no programming flexibility or gain adjustment. Ultimately, we ended up with three PSAPs to offer, each with its own strengths: one with a lower price that's easy to use and has a rechargeable battery, one that looks similar to a hearing aid and connects to an app that offers a wide range of gain and frequency adjustments, and one that looks like wireless headphones with connection to an app that allows for frequency and gain adjustments.
EDUCATING PATIENTS & DEMONSTRATING SUCCESS
As we worked through this process in our own clinic, we realized that the traditional approach to hearing aid selection appointments needed to change. Our ultimate goal for this project was to better serve our patients by prioritizing their communication challenges when making recommendations rather than moving directly to a conversation about devices. We changed the name Hearing Aid Selections to Communication Needs Assessments, an idea adopted from other clinics. Understanding what our patients identify as their communication goals gives us the opportunity to present an individualized and tailored list of device options in hopes of showing patients that we are health care providers who recommend solutions—not people who push a device.
Once these conversations changed, we needed to ensure that our patients were benefiting from the devices we dispensed. In each Communication Needs Assessment, the Client Oriented Scale of Improvement (COSI) is completed. The COSI asks patients to prioritize listening situations where they would like to see improvement in their hearing ability. The first part of the COSI is completed during the Communication Needs Assessment and serves as a guide to help the provider make targeted device recommendations. The second part is completed at an appointment following the fitting to determine if and how much the selected intervention improved communication. If a positive change is reported, you can be assured that the intervention is successful. If the patient reports experiencing no change or an increased difficulty in communicating, the intervention can be revisited and other recommendations can be made.
OUR ROLE & THE FUTURE OF PSAPs
We chose to give our patients the option of exploring PSAPs under the guidance of an audiologist or purchasing the device from the reception desk and having no input from an audiologist. Audiologists were never intended to be part of the PSAP process, but patients can choose to involve an audiologist to help with fitting, programming, and orienting the device. Mass. Eye and Ear offers unbundled services for PSAPs, which means that patients only pay for the services they want. Some patients appreciate our expertise, while some would rather explore devices on their own. If a patient purchases a PSAP at the front desk without seeing an audiologist, he or she can have confidence that he or she is buying a high-quality device recommended by our clinic.
Audiologists are not essential in the patient's process of using aPSAP, but they can prove to be invaluable to the patient's experience. PSAPs are here and OTC hearing aids are coming. We feel it is important that audiologists work to expand their services to include these devices and build a framework to incorporate new technology as it becomes available. As technology evolves, our patients’ demands for connectivity and better hearing will as well. For many patients, a PSAP is only the beginning of their hearing health care journey. PSAPs can help audiologists build rapport with patients, who will return for guidance and expertise. From patients who have normal hearing to those not ready for consistent use of amplification, these devices expand access to hearing health care and give patients a trusted provider to whom they can return as their hearing needs change.
1. Center for Devices and Radiological Health, Food and Drug Administration (2009). Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. U.S. Department of Health and Human Services.
2. Smith C, Wilber LA, Cavitt K. PSAPs vs Hearing Aids: An Electroacoustic Analysis of Performance and Fitting Capabilities. Hearing Review.
3. Bisgaard, Nikolai, et al. “Standard Audiograms for the IEC 60118-15 Measurement Procedure.” Trends in Amplification
, vol. 14, no. 2, 2010, pp. 113-120.